Diaphragm

ABSTRACT

A self inflating diaphragm having an inner tube containing air or gas under pressure and an outer flexible tube; a plug removable by a string from the inner tube permits the air or gas from the inner tube to expand the outer tube to occlude the passage; an occluding membrane may be used across the inner tube to facilitate retention of fluids and for contraception. With or without the membrane the device may constitute a supporting structure.

v Cimber United States Patent {54] DIAPHRAGM Hugo S. Cimber, 22Seven'Gables Road,

[72] Inventor:

Staten 1s1and,N.Y. 10304 221 Filed: N6v.4-,1969' [21] App1.No.: 873,848

[52] U.S.C|

51 1111.0. 58 Field 61 Search ..128/127-l30; 7 9/316; 152/340, 341;46/87-90 [56] v References 1311611 I unmzn STATES PATENTS 2,118,1655/1938 Christopher et a1. ..9/316. 3,126,936 3/1964 Beckadolph ..1s2/3411 51 Apr. 25, 1972 FOREIGN PATENTS OR APPLICATIONS 108,261 3/1899Germany.... ..128/129 487,197 5/1928 Germany ..128/129 PrimaryExaminer-Lawrence Charles Attorney-Ostro1enk, Faber, Gerb & Soffen [s71ABSTRACT A self inflating diaphragm having an inner tube containing airor gas under pressure and an outer flexible tube; a plug removable by astring from the inner tube permits the air or gas from theinner tube toexpand the outer tube to occlude the passage; an occluding membrane maybe used across the inner tube to facilitate retention of fluids and forcontraception. With or without the membrane the device may constitute asupporting structure.

5 Claims, 7 Drawing Figures DIAPHRAGM My present invention relates to avaginal diaphragm and more particularly to a self inflating diaphragmwhich may readily be placed in position and which will be inflated bymeans associated with and in the diaphragm form an appropriate seal andan air tight occlusion of the passage when in position. Inflatablestructures for insertion in the vagina have been known but have requiredexternal additional means for apparatus for effecting the inflation.

My novel diaphragm consists essentially of an inflatable annular tubularenvelope having enclosed therein another tubular annular container ofsmaller cross section than the envelope. The inner tubular container ischarged with air or other selected gas under appropriate pressure sothat when the air is vented from the inner tube it will inflate theannular inflatable outer tube to seal and occlude the'passage and toposition and retain the device.

A removable plug is provided for the inner tube; a string is attached tothe plug and passed through an appropriately sealed opening in the outertube. When the device is in the appropriate position in the passageextension of the string and a pull on the string will pull the plug fromthe inner tube permitting the air in the inner tube to expand into theouter flexible tube thereby'expanding the ring to position it firmly inplace and to occlude the passage.

A membrane may be extended across the area bounded by the inner surfaceof the inner tube. This membrane may be an extension of the material ofthe outer tube or may be a separate piece of material secured in placeand will serve also to seal the passage in which the device is located.Where desired under appropriate circumstances the membrane may beprovided with a valved opening that will permit the withdrawal ofdischarge fluid without removing the device from the passage.

An appropriate friction surface may be provided for the outer tube toensure retention of the occluding position when the outer tube isexpanded.

In addition, an appropriate removal string or other attachment may beprovided for the entire device; said removal string preferably being inaddition to the plug removal string or device.

It is, therefore, the principal object of my invention to provide a selfinflating diaphragm ring which, after it is positioned in the passage,may by a very simple malipulation be caused to inflate without theutilization of external inflating means and, therefore, serve to sealand occlude the passage.

The foregoing and many other objects of my invention will becomeapparent in the following description and drawings in which:

FIG. 1 is a plan view partly in phantom of my novel diaphragm.

FIG. 2 is a cross sectional view taken on line 22 of FIG. 1 looking in adirection of the arrows.

FIG. 3 is a cross sectional view taken on line 3-3 of FIG. 1 looking ina direction of the arrows.

FIG. 4 is a cross sectional view taken on line 44 of FIG. 1 looking in adirection of the arrows.

FIG. 5 is a view showing one method of using an applicator to insert mynovel diaphragm.

FIG. 6 is a cross sectional view taken on line 66 of FIG. 1

looking in the direction of the arrows indicating a modification of thediaphragm to permit the drawing off of fluids where the diaphragm isutilized primarily to retain fluids.

FIG. 7 is a view in perspective of the diaphragm engaging portion of theapplicator of FIG. 5.

Referring now to FIGS. 1, 2, 3 and 4, my novel diaphragm comprises arelatively stiff and preshaped annular tube 11 which is sufficientlyflexible, however, to permit simplified insertion of the diaphragmstructure. The tube 11 is provided with a removable plug 12 to which isattached a string 13; the plug may have any desired shape preferably onewhere internal air or gas pressure inside the annular tube 11 willmaintain I the plug in air blocking arrangement. The plug is arranged inan appropriate opening in the tube 11 so that it may be pulled out by apull on the string 13 which is attached to the plug 12. The tube 11 issurrounded by the highly flexible tubular envelope 14 which whenexpanded is of larger cross sectional area than the tube 11 and which isair tight or nonpermeable to any gas that may be included in the tube11. Preferably the annular envelope or tube 14 is made of polyethyleneor any other thin plastic which will resist body fluids and will beimpermeable to the air or gas which will be used as hereinafterexplained to inflate it. I

The string 13 may pass through the material of outer envelope or tube 14in any of various selected ways. The portion 15 of the string 13 betweenthe plug 12 and the inner wall of the envelope 14 may be sufficientlylong so that a pull on the end of string 13 will result in extending thestring 13 to pull out the plug without overextending the envelope 14thereby permitting the gas or air to escape from the inner tube 11 toinflate the outer tube or envelope 14. If it is desired because of thedimensional arrangements involved to ensure that the string 13 may slidewith respect to the outer envelope 14 then as shown in FIG. 4 the stringl3 may pass through an opening 16 in the outer envelope the innersurface of which is provided at the opening. 16 with an appropriatesealing adhesive 17 which will engage the outer surface of the plug 12when it is pulled against the adhesive element 17 in order to seal theopening at that point. If, however, the polyethylene or other materialfor forming the outer envelope or tube 14 is simply sealed to the stringwith sufficient slack in the string in the area 15 to permit anextension thereof to pull out the plug then such sealing arrangementwill not be needed.

Where the unit is to be used entirely as a support device rather than asa diaphragm an additional membrane is not needed. Where, however, itsprimary use is as a diaphragm thena membrane or film 20 may be supportedinside the tubular elements 11 and 14. The'membrane 20 may be eitherseparately sealed to the inner surface of the tubular element 14 or mayconstitute a two layer extension of the tubular element 14. v

In addition, as seen also in FIG. 4, a string 22 may be anchored at 23to the other end of tube 11 to provide a means for removing thediaphragm. The string 23 will pass through the outer envelope 14 being,however, sealed thereto. A sufficient additional run of string may beprovided at the section 24 thereof between the two tubes to permit fullexpansion of I the outer envelope 14. When, however, the string 22 ispulled the inner section 23 will straighten out under the pull andtransmit the mechanical pulling force to the diaphragm to assist in itsremoval.

The outer surface of the envelope 14 may be appropriately treaded orotherwise marked or formed to provide a good frictional fit against theinner walls of the passage in which it is positioned.

In operation, the entire unit 10 is inserted in the passage and rotatedthrough approximately so that it is appropriately positioned withrespect thereto. A pull on the string 13 will then remove the plug 12from the inner tube 11 which as above pointed out has been filled eitherwith compressed air or other compressed gas. The compressed air or gasescaping from the opening from which the plug 12 has been removed willnow expand into the envelope l4 and, therefore, expand the envelope 14so that the outer surface of the envelope 14 will bear against the innersurfaces of the passage and provide a sufficient'seal with respectthereto. The outer envelope 14 or outer tube will thus seatappropriately in the passage in which it is inserted conforming to anyirregularities of the passage and because of the resilience ofcompressed air or any compressed gas that may be used will exert an evenpressure on all the inner surfaces of the passage which it engagesthereby providing a seal under substantially predetermined pressure Idevice as a sealing structure, as well, the presence of the membrane 20in the unit provides appropriate sealing for retention of fluids and forcontraceptive purposes.

In the event of irregularities in the passage or the projection of thecervix into the passage in an area where it is desired to obtain theseal the membrane 20 may be made sufficiently loose or sufficientlyresilient to accommodate to such irregularity including the projectionof the cervix. Where it is made sufficiently loose for this purposeadditional material will be provided in the diaphragm section 20 topermit the diaphragm to conform itself either to the shape of the cervixor to form a pocket big enough to receive the cervix with room to spare.

My novel device thereby creates an air tight occlusion of the vaginalpassage and can be placed at any desired level in the passage. It may beused as a contraceptive ring. It may also, if placed at a lower level,be used to block off the menstrual flow and may be used to control theincontinence that may result from a vaginal fistula.

The utilization of the air tight fit and the self contained arrangementfor creating the air tight fit makes it possible for my novel device tobe fully effective and accommodate itself readily to women of differentsize. The insertion is much easier than prior devices, lessuncomfortable both to insert and to wear and more hygienic since it isreadily disposable. As an advantage over a tassette, it is easier tointroduce, better fitting and no leak should be possible as opposed to atassette which has no contraceptive value.

The string 13 may be formed so that after it removes the plug it may bepulled out entirely utilizing the sealing element 17 on the inside ofthe tubular envelope 14 to seal the opening. As a preferred alternative,the string may be pulled through the sealing element 17 to effectinflation with the plug 12 sealing against the seal 17; thereafter whenit is desired to remove the diaphragm, the string 13 may be pulled tobreak the seal and deflate tube 14. The string 22 remains in position atall times so that it may be used to provide a simplified means forremoving the unit. I

My novel device may also be used as a pessary structure as previouslydescribed. It can also be used as a plug to contain fluids; in the eventof the presence of a fistula it may be placed just below the opening tocontain the fluid. If desired, in its use as a device for containingfluids, the diaphragm element 20 may be modified as shown in FIG. 6 toprovide valve means for drawing off any fluid that might be presentafter a predetermined minimal quantity has been reached. For thispurpose a sphincter valve 30 may beplaced in an appropriate longitudinalopening 44.

An applicator rod which is preferably of relatively flexible materialmay be slidably retained in the longitudinal opening 44. The diaphragmrim is supported in the groove section 43 of the curved end 42 of handleextension 41 and is inserted at one side of the vagina until it reachesthe proper position. The groove section 43, as seen in FIG. 7 is abifurcated element having members 50,50 in which are held the flexibletips 51 so arranged as to engage the tubes 1144 to hold the diaphragm ofthe vagina now rotates the diaphragm so that the lower end of thediaphragm is rotated into position against the other side of the vagina.

When the diaphragm-is then in position a pull on the string 13 willresult in removing the plug 12 and, therefore, result in expansion ofthe outer tube 14 as previously described thereby locating the device inposition. The handle member is then pulled out.

The pulling of the string 13 may be made relatively automatic by havingthe'string l3 pass througha book 48 on the side of the handle 44, thestring being provided with a pull knob 49. The hook arrangement 48 is,of course, of smaller diameter than the pull knob 49 but the string maybe placed in the hook and as the applicator rod 45 is mo ed up into thedesired position the larger end or ball end 49 of the string 13 engagesa semi-circular portion of the hook thereby exerting a pull on thestring so that as 'the handle rod 45 is pushed up further plug 13 isremoved and expansion of the unit occurs.

In the foregoing I have described my invention in connection withillustrative embodiments thereof. Since many varia-. tions andmodifications will now be obvious to those skilled in the art, I preferto be bound not by the specific disclosure herein contained but only bythe appended claims.

Iclaim: 1. A diaphragm comprising a continuous inner annular tube and aconcentric continuous outer annular tube of flexible material containingthe inner tube; said inner tube being adapted to retain a gas underpressure, a passage between the inner and outer tube; means for sealingsaid passage and area of the diaphragm which will not interfere with anyof the organs. The sphincter valve is a well known type of valve whichis elasticized to maintain a closure but which may be opened when anobject is inserted therein. A draw off tube 31 having a tip 32 which maybe inserted through the sphincter valve may then be passed through thevalve 30, the sphincter valve engaging the sides of the tube until theopening 33 in the tube passes through the valve thereby providing apassage from above the membrane 20 through the tube 31 through whichfluids held above the membrane 20 may be drawn 011'.

Since appropriate valve arrangements for this purpose are well known nospecific valve is contemplated herein other than the fact that a valvemay be provided to permit the drawing off of fluids should that bedesirable or necessary in the specific use of the device.

In FIG. 5 I have shown a simplified means for inserting my noveldiaphragm and support into the vaginal canal. A handle 40 is providedwith an extension 41 having a curved end 42 with a groove 43 therein.The handle is also provided with a means for removing said seal fromsaid passage to permit the gas under pressure in the inner tube to passinto the outer tube and expand the outer tube to a dimension larger thanthe inner tube; and an occluding membrane supported across the openingformed by the annulus of the outer tube.

2. The diaphragm of claim 1 wherein said passage between the inner andouter tubes is formed by an opening in the inner tube; and said sealingmeans for said passage comprises a plug removable from said opening; anda string attached to said plug; said string being accessible outside thediaphragm for removal of said plug.

3. The diaphragm of claim 3'wherein an additional string is attached tosaid inner tube to facilitate removal of the diaphragm. I

4. The diaphragm of claim 1 wherein a valved normally closed opening isprovided in said membrane.

5. The diaphragm of claim 1 wherein the outer surface of the outer tubeis treaded to provide'a frictional surface.

1. A diaphragm comprising a continuous inner annular tube and aconcentric continuous outer annular tube of flexible material containingthe inner tube; said inner tube being adapted to retain a gas underpressure, a passage between the inner and outer tube; means for sealingsaid passage and means for removing said seal from said passage topermit the gas under pressure in the inner tube to pass into the outertube and expand the outer tube to a dimension larger than the innertube; and an occluding membrane supported across the opening formed bythe annulus of the outer tube.
 2. The diaphragm of claim 1 wherein saidpassage between the inner and outer tubes is formed by an opening in theinner tube; and said sealing means for said passage comprises a plugremovable from said opening; and a string attached to said plug; saidstring being accessible outside the diaphragm for removal of said plug.3. The diaphragm of claim 3 wherein an additional string is attached tosaid inner tube to facilitate removal of the diaphragm.
 4. The diaphragmof claim 1 wherein a valved normally closed opening is provided in saidmembrane.
 5. The diaphragm of claim 1 wherein the outer surface of theouter tube is treaded to provide a frictional surface.